Adverse Childhood ExperiencesNCT06821035
The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments
A study testing Garnering Resilience in Traumatized youth and families (GRIT) and Digital Citizenship Curriculum (DCC) in people with Adverse Childhood Experiences and Family Functioning, run by University of California, Irvine at 1 site in United States.
Trial summary
The goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences, Family Functioning
- What is being tested?
- Garnering Resilience in Traumatized youth and families (GRIT) and Digital Citizenship Curriculum (DCC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Youth ages 11-14 years who score in the High-Risk category (i.e., 4 or more ACEs) on the ACEs and Toxic Stress Risk Assessment Algorithm
- Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)
- Youth who are able to speak and read in English
- Has a parent/guardian/primary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention.
Who cannot join
- Youth who cannot speak and read in English
- Youth who report any alcohol or cannabis use within the last 14 days
- Youth currently enrolled in another family-based intervention (i.e., family therapy)
- Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis)
- Youth who report their caregivers' home environment is unsafe to return to, have been deemed unsafe, or require supervised visits by the Department of Children and Family Services (DCFS)
- Youth whose parent/guardian/primary caregiver declines participation will be referred to other programs in their community.
- Due to drug experimentation being common in adolescence, our interest in preventing the early initiation of regular use of alcohol and cannabis use, and youth who regularly use substances requiring a different intervention, we will enroll youth who initially report recent cannabis use but later report no use within the last two weeks and have a confirmatory negative urine drug screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Regents of the University of California, Irvine
Irvine, California, 92697-7600
Madison Spiva, 9498247688, mspiva@uci.edu
Dawn T. Bounds, Ph.D.
About this study
Official title: Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth
The goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims include:
- Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time.
- Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use.
Read more
Researchers will compare participants who are randomized to the GRIT intervention to an active control group, receiving a Digital Citizenship Curriculum, to see if those who participate in GRIT experience greater improvements in self-regulation and lower cardiometabolic risks.
Participants will:
- Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group)
- Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention
- Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits.
- Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker
- Be invited to complete a booster session at 6-months post-intervention
- Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention
Read the detailed description
Adverse Childhood Experiences (ACEs) constitute a serious public health issue, impacting almost half of adolescents and over 60% of adults in the United States. High ACEs exposure (i.e., four or more ACEs) may result in self-dysregulation (i.e., challenges managing cognitions, emotions, and behaviors) and lead to early initiation of alcohol and substance use (e.g., self-medication hypothesis) and other biopsychosocial responses, such as cardiometabolic risks (e.g., lowered heart rate variability [HRV], increased weight and blood pressure, and sleep disturbance), and emotional and/or cognitive dysregulation. Health inequities resulting from self-dysregulation are highest among minoritized and impoverished populations, who experience disproportionately higher exposure to ACEs, and early adolescence is a time in which experimentation with alcohol and drugs occurs. Although not all adolescents who experiment with drugs are later diagnosed with a substance use disorder, those who engage early (i.e., before the age of 14) and regularly are at greater risk. Youth with four or more ACEs may experience a unique type of adversity characterized by chronic, unpredictable stress shaping their perception of and responses to stress. However certain strategies, called Shift and Persist, can mitigate these exposures where one shifts their attention from adverse experiences to future-directed behaviors (e.g., healthy habit adoption, stress management), resulting in improved self-regulation and lower cardiometabolic risks. GRIT is a community health worker (CHW)-delivered psychoeducational health coaching intervention that promotes coping with high exposure to ACEs to regulate the stress response using self-regulation techniques and the development of healthy habits recommended by the California Surgeon General (e.g., supportive relationships, quality sleep, physical activity). We propose conducting a 2-arm Randomized Controlled Trial (RCT) (GRIT vs an active control [i.e., digital citizenship]) with 210 adolescent-caregiver dyads to determine GRIT's impact on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims will: Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. H1: Adolescents enrolled in GRIT will have lower rates of regular alcohol and/or cannabis use at post-intervention, 6-, and 12-month follow-ups compared to adolescents in the active control group. Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use. H2: Youth and caregiver self-regulation will mediate youth initiation of regular alcohol and cannabis use. This community-based study seeks to establish efficacy for a brief, accessible secondary prevention program. Once efficacy is established and the mechanism of action is identified, larger confirmatory efficacy studies and effectiveness trials using innovative approaches (i.e. multi-family groups and social media) in additional settings offer the opportunity to scale and decrease the research-to-practice gap for adversity-impacted youth.
- Conditions
- Adverse Childhood Experiences, Family Functioning
- Being tested
- Garnering Resilience in Traumatized youth and families (GRIT), Digital Citizenship Curriculum (DCC)
- Keywords
- Alcohol and Substance Use Prevention, Youth Risk Behaviors, Traumatized Youth, stress management, adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garnering Resilience in Traumatized youth and families (GRIT)Behavioural
Dyads randomly assigned to Garnering Resilience in Traumatized youth and families (GRIT) will receive a community health worker delivered psychoeducational intervention that includes 6 weekly sessions focused on: 1) supportive health coaching to garner resilience via psychoeducation and the promotion of buffering protective factors in both youth and caregivers and 2) facilitating self-regulation using heart rate variability (HRV) biofeedback.
Digital Citizenship Curriculum (DCC)Behavioural
Dyads randomly assigned to DCC will receive a community health worker-delivered, school grade-specific intervention that includes 6 weekly sessions focused on helping youth navigate the complexities of living in a digital world.
| Study group | Role | What they receive |
|---|---|---|
| GRIT Intervention | Experimental | Not described Receives: Behavioral: Garnering Resilience in Traumatized youth and families (GRIT) |
| Digital Citizenship Curriculumn | Active comparator | Not described Receives: Behavioral: Digital Citizenship Curriculum (DCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB)
The YRBSS is a multiple-choice survey that collects health behavior history, including questions about alcohol and cannabis use. Youth who report any substance use in the last 30 days on the YRBS will complete the Timeline Followback Method Assessment (TFB) for the last 30 days. The TFB is used to assess recent marijuana, cigarette, alcohol and other drug use. The 14-item self-administered TFB asks respondents to retrospectively estimate their daily drug over a designated period of time, from 7 days to 2 years prior to the administration date. The TFB can be used to obtain a variety of quantitative estimates of substance use, including change in substance use. Predictive validity, concordance of the TFB with other measures of drug use and strong convergence among the TFB, urine assays, self-report and collateral parent and sibling reports have been demonstrated among white and minoritized adolescents.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF)
The DERS-SF is an 18-item abbreviated version of the original, 36-item DERS questionnaire. It measures emotion regulation ability based on 6 subscales: strategies, non-acceptance, impulse, goals, awareness, and clarity. All subscales on the DERS-SF are highly correlated with the original DERS, with correlations ranging from .91 -.98. Each of the DERS-SF subscales have a Cronbach α> .70 (ranging from .79 to .91). Total scores range from 18 to 90, with higher total score on the DERS-SF indicating greater difficulties in emotion regulation.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Secondary outcomes (8)
Heart Rate Variability Assessment: EmWave Pro
The emWave Pro is a heart rhythm monitoring system that helps to observe an individual's autonomic state. This software provides HRV assessments that can be used in a wide range of applications such as quantifying HRV levels. Using HeartMath's EmWAVE Pro software, every participant will have an HRV assessment conducted that includes a resting HRV assessment (3 minutes), a stress prep (3 minutes), and a 1-minute deep breathing assessment.
Measured: Baseline, immediately after the intervention, 12 months post-intervention
Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)
PSQI is a 19-item questionnaire that assesses seven component scores; subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The PSQI has an internal reliability of .83 and test-retest reliability of .85 for the global scale. PSQI global scores range from 0 to 21, with higher scores than 5 indicating sleep disturbance.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Nutrition: CDC Youth Risk Behavior Surveillance System (YRBSS)
The 2025 middle school version of the YRBSS is a national survey that includes 3 diet and weight-related items assessing nutrition that allow for national comparison with other youth.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Physical Activity: CDC Youth Risk Behavior Surveillance System (YRBSS)
The 2025 middle school version of the YRBSS is a national survey that includes 3 items assessing physical activity that allows national comparison with other youth.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Family Functioning: Family Assessment Device (FAD)
The FAD is a 60-item survey that assesses family functioning including problem solving, communication, roles, affective responsiveness, affective involvement, and behavior control. Scores range from 1 to 4 for each response. The higher the overall score, the worse the level of family function. It has reliability at .70 for all subscales except roles.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Psychological Flexibility:
The Acceptance and Fusion Questionnaire (AFQ_Y8): an 8-item questionnaire developed for youth that examines their psychological inflexibility. It has an internal consistency of .83. Possible total scores range from 0 to 32. A higher total score indicates greater tendency to experience cognitive fusion (i.e. lower psychological flexibility).
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Psychological Flexibility:
The Acceptance and Action Questionnaire (AAQ-II): a 7-item questionnaire developed for adults to measure their psychological inflexibility and experimental avoidance. It has an internal consistency of .84 and test-retest reliability of .79- .81. Possible total scores range from 7 to 49. Higher total scores on the AAQ-II indicate higher psychological inflexibility, experiential avoidance, and more potential psychological distress. Lower total scores mean more psychological flexibility.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Psychological Stress: Perceived Stress Scale (PSS-10)
The PSS-10 is a 10-item self-measure of psychological stress. It has two subscales: perceived helplessness \& lack of self-efficacy. It has a Cronbach's alpha >.70 and a test-retest reliability of >.70. Total scores range from 0 to 40, with higher scores being indicative of higher levels of perceived stress.
Measured: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start17 Apr 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (169)Papers the sponsor has linked to this study.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of Illinois at Chicago, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Dawn Therese Bounds, University of California, Irvine
- Investigators
- Dawn T. Bounds, Ph.D., Principal investigator, University of California, IrvineNorweeta G. Milburn, Ph.D., Study director, University of California, Los AngelesKarnik Niranjan, M.D., Ph.D., Study director, University of California, Los AngelesShin Sanghyuk, Ph.D., Study director, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821035
- Sponsor's protocol ID
- 4821
- Other IDs
- 1R01DA060784-01
- Status last verified
- Mar 2026
- First submitted
- 10 Jan 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be preserved using the National Addiction \& HIV Data Archive Program (NAHDAP) repository within the Inter-university Consortium for Political and Social Research (ICPSR) platform. To protect participant privacy and confidentiality, shared data will be de-identified using participant ID's to designate each unique individual instead of names. Dates will be randomly shifted using REDCap. Data will be accompanied by detailed metadata to help ease of use. A DOI (Digital Object Identifier) will be assigned to our dataset, ensuring easy access and citation in future research.
Publications
The prevalence of adverse childhood experiences, nationally, by state, and by race or ethnicity - Child Trends. ChildTrends. Accessed August 23, 2023.
Nelson CA, Scott RD, Bhutta ZA, Harris NB, Danese A, Samara M. Adversity in childhood is linked to mental and physical health throughout life. BMJ. 2020 Oct 28;371:m3048. doi: 10.1136/bmj.m3048.
PubMed 33115717Giano Z, Wheeler DL, Hubach RD. The frequencies and disparities of adverse childhood experiences in the U.S. BMC Public Health. 2020 Sep 10;20(1):1327. doi: 10.1186/s12889-020-09411-z.
PubMed 32907569Anda RF, Felitti VJ, Bremner JD, Walker JD, Whitfield C, Perry BD, Dube SR, Giles WH. The enduring effects of abuse and related adverse experiences in childhood. A convergence of evidence from neurobiology and epidemiology. Eur Arch Psychiatry Clin Neurosci. 2006 Apr;256(3):174-86. doi: 10.1007/s00406-005-0624-4. Epub 2005 Nov 29.
PubMed 16311898Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
PubMed 9635069Merrick MT, Ford DC, Ports KA, Guinn AS. Prevalence of Adverse Childhood Experiences From the 2011-2014 Behavioral Risk Factor Surveillance System in 23 States. JAMA Pediatr. 2018 Nov 1;172(11):1038-1044. doi: 10.1001/jamapediatrics.2018.2537.
PubMed 30242348Panisch LS, LaBrenz CA, Lawson J, et al. Relationships between adverse childhood experiences and protective factors among parents at-risk for child maltreatment. Child Youth Serv Rev. 2020;110:104816.
Alabdulgader AA. Coherence: a novel nonpharmacological modality for lowering blood pressure in hypertensive patients. Glob Adv Health Med. 2012 May;1(2):56-64. doi: 10.7453/gahmj.2012.1.2.011.
PubMed 24278819Murray, Desiree W., Rosanbalm, Katie, Christopoulos, Christina, and Hamoudi, Amar. Self-Regulation and Toxic Stress: Foundations for Understanding SelfRegulation from an Applied Developmental Perspective. Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.; 2014.
Khantzian EJ. The self-medication hypothesis of substance use disorders: a reconsideration and recent applications. Harv Rev Psychiatry. 1997 Jan-Feb;4(5):231-44. doi: 10.3109/10673229709030550.
PubMed 9385000Lloyd A, Brett D, Wesnes K. Coherence training in children with attention-deficit hyperactivity disorder: cognitive functions and behavioral changes. Altern Ther Health Med. 2010 Jul-Aug;16(4):34-42.
PubMed 20653294Suglia SF, Koenen KC, Boynton-Jarrett R, Chan PS, Clark CJ, Danese A, Faith MS, Goldstein BI, Hayman LL, Isasi CR, Pratt CA, Slopen N, Sumner JA, Turer A, Turer CB, Zachariah JP; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Functional Genomics and Translational Biology; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Childhood and Adolescent Adversity and Cardiometabolic Outcomes: A Scientific Statement From the American Heart Association. Circulation. 2018 Jan 30;137(5):e15-e28. doi: 10.1161/CIR.0000000000000536. Epub 2017 Dec 18.
PubMed 29254928Hammond CJ, Chaney A, Hendrickson B, Sharma P. Cannabis use among U.S. adolescents in the era of marijuana legalization: a review of changing use patterns, comorbidity, and health correlates. Int Rev Psychiatry. 2020 May;32(3):221-234. doi: 10.1080/09540261.2020.1713056. Epub 2020 Feb 6.
PubMed 32026735Claypool N, Moore de Peralta A. The Influence of Adverse Childhood Experiences (ACEs), Including the COVID-19 Pandemic, and Toxic Stress on Development and Health Outcomes of Latinx Children in the USA: a Review of the Literature. Int J Child Maltreat. 2021;4(3):257-278. doi: 10.1007/s42448-021-00080-y. Epub 2021 Jul 11.
PubMed 34278229Maguire-Jack K, Lanier P, Lombardi B. Investigating racial differences in clusters of adverse childhood experiences. Am J Orthopsychiatry. 2020;90(1):106-114. doi: 10.1037/ort0000405. Epub 2019 Feb 28.
PubMed 30816722
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching Youth & Families Self-Regulation Skills to Disrupt the Impact of Adverse Childhood Experiences: Preventing Substance Use in Adversity- Impacted Youth
- ClinicalTrials.gov ID
- NCT06821035
- Acronym / sponsor ID
- 4821
- Conditions
- Adverse Childhood Experiences, Family Functioning
- Keywords
- Alcohol and Substance Use Prevention, Youth Risk Behaviors, Traumatized Youth, stress management, adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of Illinois at Chicago, National Institute on Drug Abuse (NIDA)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this 2-arm randomized control trial is to determine the impact of a community health worker delivered coaching intervention, GRIT, on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims include:
- Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time.
- Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use.
Researchers will compare participants who are randomized to the GRIT intervention to an active control group, receiving a Digital Citizenship Curriculum, to see if those who participate in GRIT experience greater improvements in self-regulation and lower cardiometabolic risks.
Participants will:
- Be randomized to either receive the GRIT intervention (experimental group) or the Digital Citizenship Curriculum (active control group)
- Complete 3 in-person visits at baseline, post-intervention, and 12-month post intervention
- Complete HRV assessments using emWave Pro Plus and survey assessments on REDCap during in-person visits.
- Participate in six 60-minute sessions conducted over 8 weeks via Zoom with an assigned community-health worker
- Be invited to complete a booster session at 6-months post-intervention
- Complete online measures at baseline, post-intervention, 6-month, and 12-month post-intervention
Detailed description
Adverse Childhood Experiences (ACEs) constitute a serious public health issue, impacting almost half of adolescents and over 60% of adults in the United States. High ACEs exposure (i.e., four or more ACEs) may result in self-dysregulation (i.e., challenges managing cognitions, emotions, and behaviors) and lead to early initiation of alcohol and substance use (e.g., self-medication hypothesis) and other biopsychosocial responses, such as cardiometabolic risks (e.g., lowered heart rate variability [HRV], increased weight and blood pressure, and sleep disturbance), and emotional and/or cognitive dysregulation. Health inequities resulting from self-dysregulation are highest among minoritized and impoverished populations, who experience disproportionately higher exposure to ACEs, and early adolescence is a time in which experimentation with alcohol and drugs occurs. Although not all adolescents who experiment with drugs are later diagnosed with a substance use disorder, those who engage early (i.e., before the age of 14) and regularly are at greater risk. Youth with four or more ACEs may experience a unique type of adversity characterized by chronic, unpredictable stress shaping their perception of and responses to stress. However certain strategies, called Shift and Persist, can mitigate these exposures where one shifts their attention from adverse experiences to future-directed behaviors (e.g., healthy habit adoption, stress management), resulting in improved self-regulation and lower cardiometabolic risks. GRIT is a community health worker (CHW)-delivered psychoeducational health coaching intervention that promotes coping with high exposure to ACEs to regulate the stress response using self-regulation techniques and the development of healthy habits recommended by the California Surgeon General (e.g., supportive relationships, quality sleep, physical activity). We propose conducting a 2-arm Randomized Controlled Trial (RCT) (GRIT vs an active control [i.e., digital citizenship]) with 210 adolescent-caregiver dyads to determine GRIT's impact on preventing the early initiation of regular use of alcohol and cannabis among adversity-impacted adolescents ages 11-14 who do not regularly use alcohol or cannabis at baseline. The specific aims will: Aim 1. Examine the effect of GRIT on preventing the early initiation of regular alcohol and cannabis use over time. H1: Adolescents enrolled in GRIT will have lower rates of regular alcohol and/or cannabis use at post-intervention, 6-, and 12-month follow-ups compared to adolescents in the active control group. Aim 2. Examine the role of youth and caregiver self-regulation in mediating the effect of GRIT on adolescent rates of alcohol and cannabis use. H2: Youth and caregiver self-regulation will mediate youth initiation of regular alcohol and cannabis use. This community-based study seeks to establish efficacy for a brief, accessible secondary prevention program. Once efficacy is established and the mechanism of action is identified, larger confirmatory efficacy studies and effectiveness trials using innovative approaches (i.e. multi-family groups and social media) in additional settings offer the opportunity to scale and decrease the research-to-practice gap for adversity-impacted youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRIT Intervention | Experimental | Behavioral: Garnering Resilience in Traumatized youth and families (GRIT) |
| Digital Citizenship Curriculumn | Active comparator | Behavioral: Digital Citizenship Curriculum (DCC) |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Youth ages 11-14 years who score in the High-Risk category (i.e., 4 or more ACEs) on the ACEs and Toxic Stress Risk Assessment Algorithm
- Has access to a smartphone and is willing to download applicable apps (95% of all adolescents have access to a smartphone)
- Youth who are able to speak and read in English
- Has a parent/guardian/primary caregiver (18 years or older) who is English- or Spanish-speaking and willing to participate in the intervention.
Key exclusion criteria (7 listed)
- Youth who cannot speak and read in English
- Youth who report any alcohol or cannabis use within the last 14 days
- Youth currently enrolled in another family-based intervention (i.e., family therapy)
- Youth in acute distress who are in immediate need of care (e.g., imminent risk of harm to self or others, active psychosis)
- Youth who report their caregivers' home environment is unsafe to return to, have been deemed unsafe, or require supervised visits by the Department of Children and Family Services (DCFS)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garnering Resilience in Traumatized youth and families (GRIT)Dyads randomly assigned to Garnering Resilience in Traumatized youth and families (GRIT) will receive a community health worker delivered psychoeducational intervention that includes 6 weekly sessions focused on: 1) supportive health coaching to garner resilience via psychoeducation and the promotion of buffering protective factors in both youth and caregivers and 2) facilitating self-regulation using heart rate variability (HRV) biofeedback. | Behavioural | GRIT Intervention |
| Digital Citizenship Curriculum (DCC)Dyads randomly assigned to DCC will receive a community health worker-delivered, school grade-specific intervention that includes 6 weekly sessions focused on helping youth navigate the complexities of living in a digital world. | Behavioural | Digital Citizenship Curriculumn |
Primary outcome
Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
The YRBSS is a multiple-choice survey that collects health behavior history, including questions about alcohol and cannabis use. Youth who report any substance use in the last 30 days on the YRBS will complete the Timeline Followback Method Assessment (TFB) for the last 30 days. The TFB is used to assess recent marijuana, cigarette, alcohol and other drug use. The 14-item self-administered TFB asks respondents to retrospectively estimate their daily drug over a designated period of time, from 7 days to 2 years prior to the administration date. The TFB can be used to obtain a variety of quantitative estimates of substance use, including change in substance use. Predictive validity, concordance of the TFB with other measures of drug use and strong convergence among the TFB, urine assays, self-report and collateral parent and sibling reports have been demonstrated among white and minoritized adolescents.
Emotional Regulation: Difficulties in Emotional Regulation- Short Form (DERS-SF)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
The DERS-SF is an 18-item abbreviated version of the original, 36-item DERS questionnaire. It measures emotion regulation ability based on 6 subscales: strategies, non-acceptance, impulse, goals, awareness, and clarity. All subscales on the DERS-SF are highly correlated with the original DERS, with correlations ranging from .91 -.98. Each of the DERS-SF subscales have a Cronbach α> .70 (ranging from .79 to .91). Total scores range from 18 to 90, with higher total score on the DERS-SF indicating greater difficulties in emotion regulation.
8 secondary outcomes
Heart Rate Variability Assessment: EmWave Pro
Time frame: Baseline, immediately after the intervention, 12 months post-intervention
Sleep Quality: The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Nutrition: CDC Youth Risk Behavior Surveillance System (YRBSS)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Physical Activity: CDC Youth Risk Behavior Surveillance System (YRBSS)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Family Functioning: Family Assessment Device (FAD)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Psychological Flexibility:
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Psychological Flexibility:
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Psychological Stress: Perceived Stress Scale (PSS-10)
Time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- BackgroundThe prevalence of adverse childhood experiences, nationally, by state, and by race or ethnicity - Child Trends. ChildTrends. Accessed August 23, 2023.
- Background: PubMed 33115717Nelson CA, Scott RD, Bhutta ZA, Harris NB, Danese A, Samara M. Adversity in childhood is linked to mental and physical health throughout life. BMJ. 2020 Oct 28;371:m3048. doi: 10.1136/bmj.m3048.
- Background: PubMed 32907569Giano Z, Wheeler DL, Hubach RD. The frequencies and disparities of adverse childhood experiences in the U.S. BMC Public Health. 2020 Sep 10;20(1):1327. doi: 10.1186/s12889-020-09411-z.
- Background: PubMed 16311898Anda RF, Felitti VJ, Bremner JD, Walker JD, Whitfield C, Perry BD, Dube SR, Giles WH. The enduring effects of abuse and related adverse experiences in childhood. A convergence of evidence from neurobiology and epidemiology. Eur Arch Psychiatry Clin Neurosci. 2006 Apr;256(3):174-86. doi: 10.1007/s00406-005-0624-4. Epub 2005 Nov 29.
- Background: PubMed 9635069Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- Background: PubMed 30242348Merrick MT, Ford DC, Ports KA, Guinn AS. Prevalence of Adverse Childhood Experiences From the 2011-2014 Behavioral Risk Factor Surveillance System in 23 States. JAMA Pediatr. 2018 Nov 1;172(11):1038-1044. doi: 10.1001/jamapediatrics.2018.2537.
- BackgroundPanisch LS, LaBrenz CA, Lawson J, et al. Relationships between adverse childhood experiences and protective factors among parents at-risk for child maltreatment. Child Youth Serv Rev. 2020;110:104816.
- Background: PubMed 24278819Alabdulgader AA. Coherence: a novel nonpharmacological modality for lowering blood pressure in hypertensive patients. Glob Adv Health Med. 2012 May;1(2):56-64. doi: 10.7453/gahmj.2012.1.2.011.
- BackgroundMurray, Desiree W., Rosanbalm, Katie, Christopoulos, Christina, and Hamoudi, Amar. Self-Regulation and Toxic Stress: Foundations for Understanding SelfRegulation from an Applied Developmental Perspective. Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.; 2014.
- Background: PubMed 9385000Khantzian EJ. The self-medication hypothesis of substance use disorders: a reconsideration and recent applications. Harv Rev Psychiatry. 1997 Jan-Feb;4(5):231-44. doi: 10.3109/10673229709030550.
- Background: PubMed 20653294Lloyd A, Brett D, Wesnes K. Coherence training in children with attention-deficit hyperactivity disorder: cognitive functions and behavioral changes. Altern Ther Health Med. 2010 Jul-Aug;16(4):34-42.
- Background: PubMed 29254928Suglia SF, Koenen KC, Boynton-Jarrett R, Chan PS, Clark CJ, Danese A, Faith MS, Goldstein BI, Hayman LL, Isasi CR, Pratt CA, Slopen N, Sumner JA, Turer A, Turer CB, Zachariah JP; American Heart Association Council on Epidemiology and Prevention; Council on Cardiovascular Disease in the Young; Council on Functional Genomics and Translational Biology; Council on Cardiovascular and Stroke Nursing; and Council on Quality of Care and Outcomes Research. Childhood and Adolescent Adversity and Cardiometabolic Outcomes: A Scientific Statement From the American Heart Association. Circulation. 2018 Jan 30;137(5):e15-e28. doi: 10.1161/CIR.0000000000000536. Epub 2017 Dec 18.
- Individual participant dataSharing planned: Yes. Data will be preserved using the National Addiction \& HIV Data Archive Program (NAHDAP) repository within the Inter-university Consortium for Political and Social Research (ICPSR) platform. To protect participant privacy and confidentiality, shared data will be de-identified using participant ID's to designate each unique individual instead of names. Dates will be randomly shifted using REDCap. Data will be accompanied by detailed metadata to help ease of use. A DOI (Digital Object Identifier) will be assigned to our dataset, ensuring easy access and citation in future research.
Related trials for Adverse Childhood Experiences
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
Psychological Distress, Adverse Childhood Experience
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
Psychological Distress, Adverse Childhood Experience
Enrolling by invitation
A Two-Part Intervention to Target Cardiovascular Health
Autism, Adverse Childhood Experience
Recruiting
ACEs, SIRT1, and Premature Vascular Aging in Humans
Adverse Childhood Experiences, Endothelial Dysfunction
Recruiting
Childhood Trauma, Exercise, and Cognition
Adverse Childhood Experiences
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dawn T. Bounds, Ph.D. principal investigator
University of California, Irvine
Norweeta G. Milburn, Ph.D. study director
University of California, Los Angeles
Karnik Niranjan, M.D., Ph.D. study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garnering Resilience in Traumatized youth and families (GRIT) and Digital Citizenship Curriculum (DCC) in people with Adverse Childhood Experiences and Family Functioning, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dawn T. Bounds, Ph.D. (949-742-7109, boundsd@hs.uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol, Cannabis & Other Substance Use: CDC Youth Risk Behavior Surveillance System (YRBSS)+ Timeline Followback Method Assessment (TFB) (time frame: Baseline, immediately after the intervention, 6 months post-intervention, 12 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821035, which also lists 169 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 26 Oct 2026.